A Phase 1, Multicenter, Parallel-Design, Single Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared With Participants With Normal Renal Function

The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).
For each participant, the study will last about 14 weeks, excluding screening.

Start Date24 Feb 2026

Sponsor / Collaborator

Eli Lilly & Co.

NCT07369011

/ RecruitingPhase 3

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

Start Date10 Feb 2026

Sponsor / Collaborator

Eli Lilly & Co.

NCT07401862

/ RecruitingPhase 1

A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function

The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver. The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function.
For each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.

Start Date10 Feb 2026

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Eloralintide

100 Translational Medicine associated with Eloralintide

100 Patents (Medical) associated with Eloralintide

Literatures (Medical) associated with Eloralintide

01 Mar 2026·PEPTIDES

Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes

Review

Author: Flatt, Peter R ; Bailey, Clifford J ; Conlon, J Michael

The first therapeutically useful amylin receptor (AMYR) agonist, pramlintide was based upon the structure of non-aggregating rat amylin and found limited application as an adjunct to insulin therapy. It acts centrally to induce satiety, promote weight loss, suppress prandial glucagon release and reduce prandial hyperglycaemia. Recent understanding of the heterodimeric structure of amylin-calcitonin receptor complexes and of amylin structure-function properties has assisted the design of a second generation of non-aggregating, long-acting amylin analogues. These are now advancing in clinical development and promise to provide an effective additional resource for the management of obesity and type 2 diabetes. Amongst these agents is the dual AMYR/ calcitonin-receptor (CTR) agonist, cagrilintide that has also been co-formulated into a once weekly subcutaneous injection with the long-acting glucagon-like peptide-1receptor (GLP-1R) agonist, semaglutide (CagriSema). In clinical trials, CagriSema has achieved greater effects than either component alone. A unimolecular AMYR/CTR/GLP-1R multi-agonist peptide, amycretin has been developed for weekly injection and as a once-daily tablet. Several recently developed long-acting amylin analogues have shown strong efficacy as monotherapy in clinical trials: these include eloralintide, petrelintide, Met-233 and AZD6234. Other analogues with marked efficacy in preclinical studies, including non-peptide AMYR agonists are under development. Gastrointestinal side effects, especially nausea, similar to those reported for GLP-1R agonists are commonplace during initiation and up-titration of amylin analogues but mostly resolve during continued use. Evidence is emerging that long-acting AMYR agonists may show potential therapeutic benefits in treatment of patients with fatty liver disease, diabetes-associated kidney complications and resistant hypertension.

01 Dec 2025·Molecular Metabolism

Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept

Article

Author: Tidemann-Miller, Beth ; He, Minxia Michelle ; Tham, Lai San ; Lansu, Katherine ; Pratt, Edward ; Allen, Dawn ; Coskun, Tamer ; Qu, Hongchang ; Bhattachar, Shobha N ; Bowen, Breanna ; Long, Annie ; Ibriga, Hilda ; Mather, Kieren J ; O'Farrell, Libbey ; Moyers, Julie S ; Haupt, Axel ; Briere, Daniel A ; Alsina-Fernandez, Jorge

OBJECTIVES:

Eloralintide (LY3841136), a novel amylin analog, was evaluated in translational studies to characterize its therapeutic potential for treating obesity.

METHODS:

In vitro assays were performed in cell lines selectively expressing rat or human amylin 1 receptor (AMY1R), amylin 3 receptor (AMY3R), or calcitonin receptor (CTR). In vivo studies were conducted in rats and monkeys. A phase 1, randomized, placebo-controlled, participant/investigator-blinded trial evaluated the safety and tolerability of single-ascending eloralintide doses (0.04-12 mg) in healthy participants (NCT05295940).

RESULTS:

In vitro, eloralintide preferentially activated human AMY1R (12-fold > CTR, 11-fold > AMY3R), while in rats, both AMY1R and AMY3R were activated more potently than CTR. Eloralintide induced significantly less conditioned taste avoidance in lean rats than cagrilintide, a non-selective amylin receptor agonist (p < 0.05). Eloralintide dose dependently reduced food intake and lowered body weight, primarily through fat mass loss, in diet-induced obese rats. Eloralintide demonstrated favorable pharmacokinetics in both rats and monkeys. In the phase 1 trial, 48 healthy participants had a mean body mass index of 27.5 kg/m². Nine participants in the eloralintide cohorts reported 16 adverse events, with most being mild (n = 15/16). Two participants reported 4 gastrointestinal events, including one moderate vomiting event. The pharmacokinetic profile of eloralintide supports once-weekly dosing. In eloralintide cohorts receiving single doses of 4 or 12 mg, week-4 mean percent change from baseline in body weight was -2.5% (p < 0.01) and -4.4% (p < 0.001), respectively, vs placebo (+0.6%).

CONCLUSIONS:

Once-weekly dosing with eloralintide, an AMY1R-selective agonist, may offer a promising new therapeutic with favorable gastrointestinal tolerability for the treatment of obesity.

01 Dec 2025·LANCET

Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial

Article

Author: Kazda, Christof ; Tidemann-Miller, Beth ; Mather, Kieren J ; Billings, Liana K ; Butler, Annabelle ; Coskun, Tamer ; O'Hagan, Jessica ; Tham, Lai San ; Hsia, Stanley ; Bays, Harold

BACKGROUND:

Amylin-based therapies are emerging as promising obesity medications. Eloralintide is a novel, selective amylin receptor agonist in development for weight management. We performed a phase 2, double blind, randomised, placebo-controlled trial with the aim of evaluating the efficacy and safety of a range of doses and dose escalation schemes of once-per-week eloralintide versus placebo in adults with obesity or overweight and had at least one weight-related comorbidity.

METHODS:

We enrolled 263 participants from 46 research centres in the USA. Individuals aged 18-75 years with a BMI of 30 kg/m² or higher, or a BMI of 27 kg/m² or higher with at least one weight-related comorbidity and without type 2 diabetes were randomly assigned (2:1:1:1:2:1:2) to receive once-per-week subcutaneous injections of placebo or eloralintide at 1 mg, 3 mg, 6 mg, or 9 mg, or dose escalations of 6-9 mg or 3-9 mg for 48 weeks. The primary endpoint was percent change in bodyweight from baseline after 48 weeks of treatment. Efficacy analyses included all randomly assigned participants, and safety analyses included all participants who were randomly assigned and received at least one dose of study treatment. This study was completed on Aug 14, 2025, and is registered with ClinicalTrials.gov (NCT06230523).

FINDINGS:

Between Feb 5, 2024, and Aug 14, 2025, 263 participants (mean age 49·0 years [SE 12·6], mean bodyweight 109·1 kg [22·8], BMI 39·1 kg/m² [6·8], 204 [78%] female, and 205 [78%] White) were randomly assigned to receive eloralintide (1 mg, n=28; 3 mg, n=24; 6 mg, n=28; 9 mg, n=54; 6-9 mg, n=24; and 3-9 mg, n=52) or placebo (n=53). The efficacy analyses were based on the 263 participants randomly assigned. The mean percent change in bodyweight from baseline after 48 weeks (efficacy estimand) was -9% (1 mg, 95% CI -12·6 to -6·3), -12% (3 mg, -14·9 to -9·8), -18% (6 mg, -20·7 to -14·5), -20% (9 mg, -22·7 to -17·5), -20% (6-9 mg, -22·7 to -17·0), and -16% (3-9 mg, -18·6 to -14·1), compared with -0·4% (-2·2 to 1·4) in the placebo group. The most common adverse events with eloralintide were nausea (1 mg 11%, 3 mg 13%, 6 mg 64%, 9 mg 33%, 6-9 mg 54%, 3-9 mg 25%, and placebo 14%) and fatigue (1 mg 0%, 3 mg 13%, 6 mg 29%, 9 mg 43%, 6-9 mg 46%, 3-9 mg 21%, and placebo 12%).

INTERPRETATION:

Eloralintide produced clinically meaningful, dose-dependent reductions in bodyweight over 48 weeks and was generally well tolerated, supporting eloralintide's potential use for obesity treatment.

FUNDING:

Eli Lilly.

News (Medical) associated with Eloralintide

07 Apr 2026

·www.prnewswire.com

Ascletis Announces Fixed-Dose Combination of ASC30, Once-Daily Oral Small Molecule GLP-1R Agonist, and ASC39, Once-Daily Oral Small Molecule Amylin-Selective Amylin Receptor Agonist, for Clinical Development

-Fixed-dose combination of ASC30 and ASC39 (ASC30_39 FDC) tablets, dosed orally in dogs, demonstrated comparable pharmacokinetics to those observed in their respective monotherapies in a head-to-head study. The fixed dose combination had excellent oral bioavailability, drug exposure and a half-life of up to 12 hours. These data support ASC30_39 FDC tablets as a potential novel one-pill-once-daily therapy for obesity. -ASC30_39 FDC demonstrated excellent compatibility between ASC30 and ASC39 when combined together, with room temperature stability and a small pill size. -ASC30 is a Phase III-ready oral small molecule GLP-1R agonist that had a favorable gastrointestinal (GI) profile with half the rate of vomiting vs. orforglipron, when both drugs are dosed with weekly titration. -ASC39, an oral small molecule amylin-selective amylin receptor agonist, demonstrated eloralintide-like amylin selectivity and efficacy in preclinical models. -Submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC oral tablets is expected in the third quarter of 2026. HONG KONG, April 7, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30, once-daily oral small molecule GLP-1R agonist and ASC39, once-daily oral small molecule amylin-selective amylin receptor agonist, for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC oral tablets for the treatment of obesity in the third quarter of 2026. ASC30_39 FDC tablets, dosed orally in dogs, demonstrated excellent oral bioavailability, high drug exposure and a long half-life of up to 12 hours. These key parameters of ASC30_39 FDC tablets are consistent with those observed in their respective monotherapies in a head-to-head dog study. Furthermore, ASC30_39 FDC tablets, developed utilizing Ascletis' proprietary formulation technology, demonstrated a good compatibility between ASC30 and ASC39 with room temperature stability and a small pill size. The combination of the excellent pharmacokinetic profile of ASC30_39 FDC, the potential best- in-class efficacy and gastrointestinal (GI) tolerability of ASC30 and the first eloralintide-like small molecule amylin support ASC30_39 FDC tablets as a potential novel one-pill-once-daily therapy for the treatment of obesity. ASC30 is a Phase III-ready oral small molecule GLP-1R agonist that had a favorable gastrointestinal (GI) profile with half the rate of vomiting vs. orforglipron, when both drugs are dosed with weekly titration in non-head-to-head studies (Press release). As a clinical development candidate, ASC39 is a potent and amylin-selective oral small molecule amylin receptor agonist and demonstrated eloralintide-like amylin selectivity and efficacy in preclinical models. "Selection of this fixed dose combination, which we believe is the first publicly announced co-formulation of an oral GLP-1 and an oral amylin, is an important step in the development of a new oral, potentially synergistic combination of ASC30 and ASC39 for the treatment of obesity," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "We believe this fixed dose combination, which combines the key features of high bioavailability, high drug exposure, a long half-life, and the convenience of a small pill, has the opportunity to improve patient outcomes for the treatment of obesity." About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, and ASC39, a potent and amylin-selective oral small molecule amylin receptor agonist, for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visit . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR Teams +86-181-0650-9129 (China) [email protected] [email protected] SOURCE Ascletis Pharma Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 1

11 Mar 2026

·www.biospace.com

Prasad Out at FDA, Lawmaker Takes Action on Rare Disease Rejections and a Spate of Obesity Data

Rare disease biotech stocks pop on the news that Vinay Prasad, the FDA’s chief biologics regulator, will depart the FDA at the end of April; Sen. Ron Johnson launches an investigation into recent rare disease drug rejections; and Roche and Zealand’s amylin analog fails to match investor expectations—and Eli Lilly’s rival candidate—in a mid-stage trial. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart After Friday’s news that Center for Biologics Evaluation & Research Chief Vinay Prasad will leave the FDA—again—at the end of April, stocks for several rare disease drug developers popped. UniQure, in particular, was up 51% in premarket trading on Monday. Prasad in a meeting last Thursday with select journalists called the biotech’s Huntington’s treatment AMT-130 a “failed” therapy, according to STAT News . Shares of Replimune and REGENXBIO —which have suffered rejections during the past year—also rose. One person who is not impressed with the plethora of rare disease drug rejections of late—H.C. Wainwright said in a note Tuesday that there have been at least five cell and gene therapies they believe could have been approved under prior FDA officials—is Wisconsin Senator Ron Johnson . Tuesday, Bloomberg News reported that Johnson has launched an investigation into these recent denials. Johnson called the FDA’s request that uniQure conduct a sham surgery-controlled trial of AMT-130 “bureaucratic idiocy,” according to the publication. Meanwhile, uniQure and the FDA appear to be on different pages regarding the design of this prospective trial, with uniQure Chief Medical Officer Walid Abi-Saab referring to a 10-12 hour surgery during which [burr] holes would be drilled in patients’ skulls and Prasad claiming on a media call last week that it would require only “one to three nicks in the scalp.” In other news, no episode of The Weekly would be complete without our weekly weight loss segment. Roche and Zealand Pharma’s amylin analog fell short of Eli Lilly’s rival candidate eloralintide; AbbVie reported what analysts called “competitive” results, with its amylin analog eliciting nearly 10% weight loss at 13 weeks in a Phase 1 trial; and Regeneron touted a much-needed Phase 3 win for Hansoh-partnered dual GLP-1/GIPR agonist olatorepatide in China. Beyond data, Novo Nordisk and Hims & Hers are together again, with Novo striking a deal to sell its injectable and oral GLP-1 medicines through the telehealth provider. Elsewhere on the business side of biopharma, experts are reporting a cut-throat atmosphere behind doors on the M&A front as the supply of companies available to buy dwindles.

Phase 1Phase 3Clinical Result

06 Mar 2026

·allsci.com

Roche partner Zealand’s Phase II data for petrelintide shows placebo-like safety

Copenhagen-based Zealand Pharma announced positive petrelintide Phase II results from the ZUPREME-1 dose-finding trial, reporting up to 10.7% mean body weight reduction at 42 weeks in people with overweight and obesity. Petrelintide is a long-acting amylin analog designed for once-weekly subcutaneous administration. The drug is being developed through an exclusive collaboration between Zealand Pharma and Roche signed in 2025, which grants Roche co-development and co-commercialization rights. The Phase II data for petrelintide produced weight loss below the levels reported for leading GLP-1–based therapies, with semaglutide demonstrating roughly 13%-15% reductions and tirzepatide around 20% in longer-duration Phase III trials. While this suggests more modest efficacy as a monotherapy, petrelintide showed a placebo-like safety profile. Roche has indicated that the drug may ultimately be positioned as part of combination regimens, potentially alongside its GLP-1 pipeline candidate CT-388, which the company acquired through its purchase of Carmot Therapeutics. ZUPREME-1 (NCT06662539) is a randomized, double-blind, placebo-controlled, parallel-group, multinational Phase II trial conducted across 33 sites in the United States, Poland, and Romania. The study enrolled 493 adults with obesity or overweight with weight-related comorbidities randomized across five petrelintide dose arms and placebo. Dosing involved once-weekly subcutaneous petrelintide with dose escalation every four weeks over a 16-week period, followed by maintenance through week 42 and a nine-week safety follow-up to week 51. The primary endpoint, percentage change in body weight from baseline to week 28, was met across all five petrelintide arms with statistical significance versus placebo. Weight reduction continued through week 42, reaching up to 10.7% (efficacy estimand) compared to 1.7% with placebo (p<0.001). In the maximally effective arm, 98% of participants escalated to the targeted maintenance dose. The tolerability profile was the trial’s distinguishing feature. Treatment discontinuation due to adverse events was 4.8% in the maximally effective petrelintide arm versus 4.9% with placebo. There were no cases of vomiting and no GI-related discontinuations at the maximally effective dose. Nausea rates were lower than in the prior 16-week Phase Ib trial, which used faster dose escalation, and nearly disappeared after participants reached maintenance dosing. No unexpected safety signals emerged, including for alopecia, fatigue, or neuropsychiatric events. Overall trial withdrawal was 8.4% across petrelintide arms versus 13.6% with placebo. Zealand plans to initiate Phase III development later in 2026, with the ZUPREME-1 data informing trial design. Final results including the follow-up period are expected at a scientific conference in 2026. Topline data from ZUPREME-2, evaluating petrelintide in people with overweight or obesity and type 2 diabetes, are anticipated in the second half of 2026. A Phase II combination trial with CT-388 is planned for the first half of 2026. Petrelintide mimics endogenous amylin, a peptide co-secreted with insulin from pancreatic beta cells in response to nutrient intake. Amylin receptor activation reduces body weight by restoring sensitivity to the satiety hormone leptin and inducing earlier satiation. This mechanism is distinct from GLP-1 receptor agonism, the pathway exploited by semaglutide and tirzepatide. The tolerability data from ZUPREME-1 are notable because GI side effects, particularly nausea and vomiting, remain the primary cause of treatment discontinuation with GLP-1-based obesity therapies, limiting long-term adherence. The amylin analog weight loss space has drawn considerable investment. Key competitors include: Eli Lilly’s eloralintide, a selective amylin receptor agonist being readied for Phase III as a monotherapy and in combinations with other metabolic targets such as GLP-1 or GIP receptor agonists. Novo Nordisk’s amycretin, a dual GLP-1 and amylin receptor agonist in oral formulation that has produced Phase Ib/IIa weight loss data and is advancing toward Phase III. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 2Clinical ResultAcquisitionPhase 3Phase 1

100 Deals associated with Eloralintide

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Apnea, Obstructive	Phase 3	United States	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	China	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	Japan	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	Argentina	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	Australia	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	Brazil	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	Canada	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	Germany	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	India	Eli Lilly & Co.	10 Feb 2026
Sleep Apnea, Obstructive	Phase 3	South Korea	Eli Lilly & Co.	10 Feb 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06230523 (Pubmed \| Lancet)	Phase 2	Obesity	263	Eloralintide 1 mg	vqgtdzyxdb(cgaptcwsrs) = livwfivird jddhxksqrw (ejvopujcft, -12.6 to -6.3)	Positive	01 Dec 2025
				Eloralintide 3 mg	vqgtdzyxdb(cgaptcwsrs) = xjrtpfihsh jddhxksqrw (ejvopujcft, -14.9 to -9.8)
NCT05295940 (Pubmed \| Mol Metab)	Phase 1	Obesity	48	Eloralintide	qtapdqpwxa(hfztviubbu) = fdhoaeizzn feixovnbnu (zcfjifbedq ) View more	Positive	01 Dec 2025
				Placebo	mgffoyoyro(ospybnqnfy) = jzakvhqoty csfgunqptn (rcrsnoobjh ) View more
NCT06230523 (Company_Website \| Lancet) Manual	Phase 2	Overweight \| Obesity	263	Eloralintide 1 mg	dkddziatxy(rcasbjfniv) = xnttamiawr xoyhbqgkcn (wfyeqvhfct ) Met	Positive	06 Nov 2025
				Eloralintide 3 mg	dkddziatxy(rcasbjfniv) = cgrllfxhcm xoyhbqgkcn (wfyeqvhfct ) Met
NCT06916091 (ADA2025 \| NEWS) Manual	Phase 1	Obesity	100	Eloralintide dose1	tvtkjvxywx(pbxeycxghu) = rubdcepjhi psmszvipos (xlilxatvsh ) View more	Positive	17 Jun 2025
				Eloralintide dose2	tdxpzkqkqq(sigrcbhphs) = mmmwvnsrgd oxqwiccwyq (jnkrzhlefk )

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